OLIG2 Inhibitor CT-179 for Recurrent and Newly-diagnosed Glioblastoma | NCT07739017

NCT07739017

Overview

NCT ID: NCT07739017
Lead Sponsor: Olivia Newton-John Cancer Research InstituteOTHER
Official Title: A Phase 1, Two-Part, Accelerated Dose Titration Trial of CT-179 as Monotherapy in the Treatment of Recurrent Glioblastoma and in Combination With Radiation Therapy in the Treatment of Newly Diagnosed MGMT-Unmethylated Glioblastoma
Brief Summary: This is a first-in-human Phase 1 two-part, open-label, multi-center, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and maximum tolerated dose (MTD) of CT-179 in patients with recurrent glioblastoma and newly diagnosed MGMT-unmethylated glioblastoma who are eligible to receive radiation therapy following surgery, and to establish the recommended Phase 2 dose.
Conditions: Recurrent Glioblastoma
Newly Diagnosed MGMT Unmethylated Glioblastoma

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Male or female aged ≥ 18 years at the time of signing informed consent

Supratentorial, histologically confirmed diagnosis of primary GBM that meets the current diagnostic classification: 2021 WHO Classification of Tumors of the Central Nervous System

KPS score ≥ 70

Adequate organ function

Contraception during study participation, as applicable

Able to swallow tablets

Exclusion Criteria:

Treatment with an investigational agent within the last 30 days excluding 5- aminolevulinic acid (5-ALA)

Placement of Gliadel wafers or similar local therapy at time of surgery

Receive bevacizumab

Evidence of intracranial or intra-tumoral hemorrhage

Significant concomitant disorder or serious intercurrent illness

History of prior malignancy, except adequately treated non-melanoma skin cancer, carcinoma in-situ of the cervix, or disease-free for more than 5 years

Treatment for HIV, hepatitis B, or hepatitis C

Any gastrointestinal disorder that could result in reduced absorption of CT-179

Any psychiatric illness or social situation that would limit compliance with study requirements

Dose of dexamethasone higher than 4 mg/day within 1 week of the first dose of study medication